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Solitary serum methotrexate level 36 hours post high-dose methotrexate: A safe, efficacious, and cost-effective strategy to monitor methotrexate toxicities in childhood leukemia in resource-limited centers.
Pediatric Blood & Cancer ( IF 3.2 ) Pub Date : 2020-05-13 , DOI: 10.1002/pbc.28387
Sanjeev Khera 1 , Rajan Kapoor 2 , Suman Kumar Pramanik 3
Affiliation  

BACKGROUND The standard practice during high-dose methotrexate (HD-MTX) in acute lymphoblastic leukemia (ALL) to mitigate toxicity is to serially monitor levels till serum MTX < 0.01 μmol/L. Most resource-limited centers lack in-house access to MTX levels, and therefore repeated monitoring is costly and cumbersome. We studied the efficacy and safety of "solitary 36 hours post HD-MTX levels (MTX36 )." PROCEDURE This prospective observational study consecutively enrolled children with ALL receiving HD-MTX. Cycles with unavailable MTX36 and MTX36 > 10 μmol/L were excluded. HD-MTX was administered over 24 hours (BFM-2009 protocol) with 12 hours of prehydration. MTX36 were performed at other centers. Leucovorin was given in six hourly doses 36 hours post HD-MTX. Hydration was continued until the last dose of leucovorin. MTX toxicities, including change of creatinine from baseline at 36 hours (∆Cr36 ), were noted. Two groups depending on MTX36 (≤1 μmol/L vs > 1 μmol/L) received six versus eight doses of leucovorin, and toxicities were compared. RESULTS Twenty-nine children with median age five years (1-11) who received 100 HD-MTX cycles with a median MTX dose of 3 g/m2 (2-5) were analyzed. The median MTX36 level was 1.165 μmol/L (0.1-7.32). Toxicities of HD-MTX (CTCAE-4.0): transaminitis-22%; creatinine elevation ≥ 1.25 times baseline-24%; cytopenias-16%; mucositis-17%; acute kidney injury (AKI)-6%. All toxicities were ≤CTCAE grade 3. Creatinine elevation, AKI, and mucositis were significantly higher in the group with higher MTX36 . There was no correlation (r = 0.3) between ∆Cr36 and MTX36 . MTX36 was thrice more economical than the standard protocol. CONCLUSION MTX36 is a potential cost-effective, efficacious, and safe limited sample strategy to monitor HD-MTX, particularly in centers where in-house MTX levels are unavailable.

中文翻译:

高剂量甲氨蝶呤后36小时的单独血清甲氨蝶呤水平:在资源有限的中心监测儿童白血病中甲氨蝶呤毒性的安全,有效且具有成本效益的策略。

背景技术在急性淋巴细胞白血病(ALL)中高剂量甲氨蝶呤(HD-MTX)治疗期间,减轻毒性的标准做法是连续监测血药水平直至血清MTX <0.01μmol/ L。大多数资源受限的中心都缺乏内部对MTX级别的访问权限,因此重复监视既昂贵又麻烦。我们研究了“ HD-MTX水平后36个小时单独(MTX36)”的疗效和安全性。程序这项前瞻性观察研究连续纳入了所有接受HD-MTX治疗的ALL儿童。排除不可用的MTX36和MTX36> 10μmol/ L的循环。HD-MTX在24小时内(BFM-2009方案)进行了12小时的预水合给药。MTX36在其他中心进行。HD-MTX后36小时,以六小时一次的剂量给予白细胞素。继续水合作用直到最后一剂亚叶酸。MTX毒性 包括在36小时时肌酐从基线的变化(∆Cr36)。取决于MTX36的两组(≤1μmol/ L vs> 1μmol/ L)分别接受了六剂与八剂亚叶酸的剂量,并比较了毒性。结果分析了29位5岁中位年龄(1-11岁)的儿童,他们接受了100次HD-MTX周期治疗,中位MTX剂量为3 g / m2(2-5)。MTX36中位数为1.165μmol/ L(0.1-7.32)。HD-MTX(CTCAE-4.0)的毒性:氨氮炎22%;肌酐升高≥基线的1.25倍-24%; 血细胞减少症-16%; 粘膜炎-17%; 急性肾损伤(AKI)-6%。所有毒性均≤CTCAE3级。MTX36较高的组肌酐升高,AKI和黏膜炎明显更高。ΔCr36与MTX36之间没有相关性(r = 0.3)。MTX36比标准协议便宜三倍。
更新日期:2020-05-13
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